BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID 19 HOME TEST

    MDR report key: 13343796 · Received January 24, 2022

    Report

    Report Number
    MW5106942
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 19, 2022
    Report Date
    January 20, 2022
    Manufacturer
    ELLUME LIMITED
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED A FALSE POSITIVE COVID REPORT IN THE ELLUME COVID 19 HOME TEST. NEXT DAY LAB TEST SHOWED NEGATIVE RESULT (WITHIN TEN HOURS OF HOME TEST). LOT # 21196-956, ANALYZER ID (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747510 COVID 19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ELLUME LIMITED 21196-956

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male